Kornimate/medical-research-clean huggingface dataset:
plantar pressure distribution in diabetic foot ulcer

Conditions: Diabetic Foot Ulcer

Summary: the goal of this clinical trial is to find out the changes in peak pressure and pressure-time integral after twelve weeks from the initial utility of foot insoles and eight weeks later as a follow-up in diabetic foot ulcers. participants will be randomly assigned to foot insole, medication, and wound care (study group) or medication and wound care (control group).

insole design the foot insole is 5 mm thick under the flat part of the forefoot and the modification is done by changing the position of the metatarsal bar. this was another 5 mm above the flat part of the foot insole. the proximal/distal position of the metatarsal rod and the cavity distal to the rod (large cavity) were defined using the plantar pressure distribution. the position and shape of the distal end of the metatarsal bar were defined by a line in the area where the plantar pressure was 75% of the maximum plantar pressure. this line also defined the void's proximal border. the void's distal border was housed near the area of peak plantar pressures, where pressure was 10% of peak plantar pressure. the void measured 3 mm in depth. after completing the initial design of the metatarsal bars and void, two variations were created by relocating the metatarsal bar proximal and distal by 2-4% of the insole length depending on the position of the foot ulcer. based on a previous pilot study, this proportion equates to a distance of 5-7 mm on a size 38 orthotic insole. the orthotic insoles were made of medium-density (ethylene-vinyl acetate) eva (50° shore a) and were manufactured on a cnc machine.

Eligibility criteria:
* being between the ages of 50 and 65 years * males and females * with midfoot ulcer grades ii or iii * diabetic foot ulcer * the duration between 6 months and one year * diabetes mellitus incidence between seven and ten years * glycated hemoglobin between seven and nine (7 to 9%) * body mass index between 25 and 30 kg\|m2 exclusion criteria: * reynaud's disease * peripheral arterial disease * foot deformities * foot burns.
immunomodulation of e.coli nissle 1917 in patients with grass pollen rhinoconjunctivitis

Conditions: Rhinoconjunctivitis

Summary: due to the worldwide increasing prevalence of the allergic rhinoconjunctivitis, new therapeutical strategies are needed. the symptomatic treatment with topical and systemic antihistamines and corticosteroids are often insufficient. e.coli nissle 1917 has immunomodulatory capacities and reveals less side effects. e.coli nissle 1917 has no sedative properties and exhibits no hepatotoxic qualities. thus, e.coli nissle 1917 represents a new relevant therapeutical agent.


Eligibility criteria:
inclusion criteria: * clinical relevant grass pollen allergy with required treatment since 2 years * positive skin prick test to grass * positive sige towards grass (cap 2) * written informed consent exclusion criteria: * perennial rhinoconjunctivitis * sinusitis * chronic diarrhoea and other existing severe gastrointestinal diseases * current specific immunotherapy to grass pollen

Keywords: e.coli mutaflor grass pollen rhinoconjunctivitis rhinoconjunctivitis caused by grass pollen
cardioneuroablation for the treatment of vagally-mediated atrial fibrillation.

Conditions: Atrial Fibrillation Paroxysmal

Summary: pulmonary vein isolation (pvi) is a cornerstone for catheter ablation of atrial fibrillation (af), however, exact mechanisms of pvi efficacy remain debatable. it has been postulated that in patients with increased vagal tone af can be treated by attenuation of parasympathetic drive to the heart using cardioneuroablation (cna) by means of radiofrequency (rf) of the ganglionated plexi, however, data in literature and guidelines are lacking. the objective of this study is to examine the mid-term efficacy of rf-cna targeting the right anterior ganglionated plexus (ragp) in management of af using right-atrial approach only.

calculation of deceleration capacity (dc) was derived from the result of 1-minute monitoring of r-r intervals recorded using electrophysiology (ep) system. double access to the right femoral vein was obtained under ultrasound guidance. four- or ten-pole diagnostic electrode was introduced into the coronary sinus and an open-irrigated or 8 mm ablation catheter (ac) was advanced into the superior vena cava. the location of ragp was determined purely anatomically at the sites of fragmented potentials below the superior vena cava ostium and the superior-septal aspect of the right atrium in the left anterior oblique (lao) view and was guided fluoroscopically. rf applications were delivered and were continued until heart rate (hr) acceleration \>30% was achieved or rf time exceeded 120 s. clinical follow-up (fu) consisted of multiple ambulatory visits with standard ecg and a 7-day holter during the fu period. during fu visits, a detailed history of any palpitations, episodes of af, and hospitalizations for cardiac arrhythmias was collected.

Eligibility criteria:
inclusion criteria: * paroxysmal atrial fibrillation * deceleration capacity \>7ms exclusion criteria: * permanent af lasting more than one year or persistent af lasting more than 7 days * af secondary to electrolyte imbalance, thyroid disease, alcohol abuse, or other non-heart related causes * anteroposterior dimension of the left atrium in the echocardiography ≥ 5.5 cm * significant valvular disease * prosthetic valve * heart failure new york heart association (nyha) class iii/iv * previous af ablation * history of a persistent oval opening/atrial septal defect closure * history of left atrial appendage closure * atrial myxoma * presence of a cardiac pacemaker, defibrillator or cardiac resynchronization therapy device * symptomatic hypotension * history of pericarditis * congenital heart disease * history of coagulation disorders * contraindications to oral anticoagulation * contraindications to computed tomography or magnetic resonance imaging * history of transplantation * severe lung disease * chronic renal failure defined as estimated glomerular filtration rate (egfr) \<30 ml/min/m2 * cancer * significant infection * life expectancy less than one year * lack of informed consent to participate in the trial * participation in another trial

Keywords: atrial fibrillation vagally-mediated cardioneuroablation
the eye in orbit: ucf adaption

Conditions: Spaceflight Associated Neuro-Ocular Syndrome; SANS

Summary: the goal of this study is to understand the impact of space travel on the eyes. space flight impacts numerous aspects of ocular anatomy and physiology. current hypotheses are based on pressure changes within and around the optic nerve. retinal and choroid blood drainage may be affected by microgravity associated cerebrospinal fluid pressure changes. recently, a new imaging modality, optical coherence tomography angiography (octa), has been able to reveal micro vascular changes in the retina and choroid. to date, no microgravity ocular imaging tests have been published using octa. in this study the researchers aim to describe microgravity circadian choroidal and retinal vasculature using multimodal imaging including octa to better understand space associated ocular changes.


Eligibility criteria:
inclusion criteria: - astronauts in the ax1/rakia mission, which was scheduled for space flight in late march 2022. exclusion criteria: * adults unable to consent * individuals who are not yet adults (infants, children, teenagers) - * pregnant women * prisoners.

Keywords: sans spaceflight associated neuro-ocular syndrome optical coherence tomography angiography octa space astronaut
covid-19 vaccination of immunodeficient persons (covaxid)

Conditions: Covid19

Summary: the study is designed as an open, non-randomized, phase iv cohort study in which the mrna vaccine comirnaty will be given in two doses. analyses will be performed on blood and saliva, investigating humoral and cellular vaccine responses. occurence of local or systemic reactogenicity will be evaluated, as well as adverse events. the study will include persons with primary or secondary immunosuppressive disorders, as well as immunocompetent persons, with the aim of investigating if the immune responses after given comirnaty mrna vaccine against covid-19.

in this study with 450 patients with primary or secondary immunosuppressive disorders (patients with primary immunodeficiency, hiv infected patients, patients with allogenic stem cell transplantation/car t cell treated, solid organ transplanted, and patients with chronic lymphatic leukemia) from karolinska university hospital, and healthy controls of 90 individuals for comparison, we will investigate the safety and the immune responses after mrna vaccination with comirnaty after two doses, under 6 months of time for each participant. the study is in collaboration with research groups at karolinska institutet and scilifelab, with planned in-depth detailed analyses of antibody responses as well as cellular responses. the study has obtained permission from swedish medical agency and swedish ethical review authority.

Eligibility criteria:
inclusion criteria: 1. individuals ≥18 years old 2a. in the opinion of the investigator, individuals with immunosuppressive disease who meet one of the following criteria: * primary immunodeficiency * human immunodeficiency virus (hiv)-infection * allogeneic stem cell transplantation / chimeric antigen receptor (car t cell) therapy * solid organ transplant * chronic lymphatic leukemia or 2b. in the opinion of the investigator, individuals without immunosuppressive disease or treatment without significant co-morbidity 3. provision of signed informed consent to participate in the study exclusion criteria: 1. previous or ongoing coronavirus disease-19 (covid-19). 2. coagulation disorders, other conditions associated with prolonged bleeding time or anticoagulant treatments, which according to the investigator contraindicate intramuscular injection. conditions which can be corrected with measures such as platelet concentrate treatments, coagulation factors or other measures for people responsible for anticoagulants are not exclusion criteria. 3. planned to receive another vaccine within 14 days before the first dose of the study vaccine, or during the period from the first dose of the study vaccine up to 14 days after the second dose of the study vaccine, and vaccination with another vaccine which in the investigator's opinion cannot be planned outside these time periods 4. pregnancy or breast feeding. 5. hypersensitivity to the active substance or to any of the excipients contained in the vaccine 6. individuals who cannot understand the informed consent. 7. individuals who for other reasons are considered by investigators as not suitable for inclusion
collection of performance data from the integrated sensor and infusion set. trial 4

Conditions: Diabetes Mellitus Type I; Diabetes Mellitus Type II

Summary: this is a multi-center, non-randomized, and interventional study in which subjects will use the integrated sensor and infusion set with minilink transmitter and the medtronic paradigm® veo™ insulin pump (sensor augmented pump) for 15 days. the purpose of this study is to collect performance data on the integrated sensor and infusion set for approximately 15 days, with the intention for each subject to wear 5 sets for 3 days each.


Eligibility criteria:
inclusion criteria: * subject is 18 years of age or older at time of screening * subject has a clinical diagnosis of insulin requiring diabetes, as determined by investigator. * subject is currently using a medtronic paradigm sensor augmented insulin pump and has been so for a minimum of 3 months at time of enrollment. * subject has continuous glucose monitoring experience (min 30% of cgm use within the month prior to enrollment). * subject has an average of 3 smbg per day (verified via carelink) during the month prior to enrollment. * subject is willing to wear the study devices for the duration of the study * subject is willing to perform frequent (min 7 per day) smbgs during study device wear * subject is willing to keep a short diary during the device wear. exclusion criteria: * female subject is pregnant, per urine pregnancy test performed at time of enrollment in women of child bearing age. * female subject plans to become pregnant during the course of the study. * subject is unable to tolerate tape adhesive in the area of the placement of the study device. * subject has any unresolved adverse skin condition in the area of the placement of the study device (e.g. psoriasis, rash, staphylococcus infection). * the subject is not deemed to be an appropriate candidate for the study by the investigator for any reason.
long term results of combined transpupillary thermotherapy (ttt) indocyanine green (icg) based photodynamic therapy (pdt) in choroidal melanoma

Conditions: Choroidal Melanoma

Summary: this is a report of 10 years results of combined transpupillary thermotherapy (ttt) treatment with indocyanine green (icg) in controlling small and medium-sized choroidal melanomas.

the study was done in a clinical practice setting. forty six eyes of 46 patients with small or medium-sized choroidal melanomas were treated with i-ttt using infrared light delivered from a diode laser. all patients were evaluated to rule out systemic metastasis and underwent a complete ophthalmological evaluation including: slit lamp biomicroscopy, dilated fundus examination, fluorescein angiography, optical coherence tomography and a/b ultrasonography. main outcome measures were: changes in visual acuity, complications associated with the treatment and local control of the tumor.

Eligibility criteria:
inclusion criteria: * small and medium-sized choroidal melanoma * patients older than 18 years old. * patients who can read and signed the informed consent. exclusion criteria: * patients with ocular inflammation. * patients with another active ocular disease.

Keywords: transpupillary thermotherapy choroidal melanoma icg-photodynamic therapy
healthy volunteers study

Conditions: Ovarian Cancer; Genetic Predisposition to Disease

Summary: the purpose of this study is to examine the role of the bacterial environments and metabolites in the early detection and prediction of ovarian cancer development. vaginal swabs and stool samples will be collected from healthy volunteers, or those without a known ovarian cancer diagnosis or genetic ovarian cancer risk. these samples will be compared to samples from participants with increased cancer risk and ovarian cancer diagnoses.

this study will examine the role of the microbiome and its metabolites in early detection and prediction of ovarian cancer development. it has been previously shown that the composition and function of the microbiome may play a role in the development and progression of several types of cancer. one proposed mechanism by which the microbiome may contribute to cancer development is through the production of certain metabolic byproducts. such metabolites produced or modified by the microbiome have emerged as a prominent factor with potential local and systemic effects on the host, and were proposed to mediate the microbiome's contribution to cancer development. microbial metabolites can promote cancer development by activating signaling pathways that promote cell growth and survival. in addition, the microbiota affects carcinogenesis through the release of carcinogenic molecules, such as genotoxins, and through the production of tumor-promoting metabolites. furthermore, microbial metabolites have been studied as potential biomarkers for cancer, with some research suggesting that certain microbial metabolites may be able to distinguish between healthy individuals and those with cancer. the microbiome of the female reproductive tract is relatively understudied compared to the gut microbiome, but recent studies have shown that it is present and diverse in various parts of the reproductive tract such as the vagina, cervix, and fallopian tubes. however, a microbiome or metabolome signature predictive of ovarian cancer has not yet been established. eligible individuals will be consented to provide a one-time, self-administered vaginal swab sample and stool sample. clinical research assistants/coordinators, genetic counselors, and/or study physicians will consent patients and process and store the samples of consented participants. participants will be provided a stool collection kit at the time of consent with instructions for providing the sample and sending it back to the laboratory.

Eligibility criteria:
inclusion criteria: * has ovaries exclusion criteria: * genetic mutations which increase risk of ovarian cancer: brca1/2, brip1, palb2, lynch syndrome (mlh1, msh2/epcam, msh6) and atm * no genetic testing results or unknown genetic status * prior cancer diagnosis * prior cancer treatment * hrt use * antibiotic use (1 month prior to providing sample)

Keywords: vaginal metabolome ovarian cancer
va combined with pd-1 inhibitor for the treatment of relapsed and refractory aml and high-risk mds

Conditions: Relapsed Acute Myeloid Leukemia; Refractory Acute Myeloid Leukemia; Myelodysplastic Syndromes; Minimal Residual Disease

Summary: the efficiency and safety of pd-1 inhibitor in combination with venetoclax and hypomethylation agent in relapsed/refractory acute myeloid leukemia or high-risk myelodysplastic syndrome remain uncertain. in this study, the investigators aimed to assess safety and response to a new pd-1 inhibitor-based triple-drug combination regimen (venetoclax + hypomethylation agent + pd-1 inhibitor) in relapsed/refractory acute myeloid leukemia and high-risk myelodysplastic syndrome patients, or who had positive minimal residual disease.


Eligibility criteria:
inclusion criteria: * patients diagnosed with relapsed and refractory acute myeloid leukemia (aml) and patients diagnosed with myelodysplastic syndrome (mds) who require chemotherapy treatment. * patients who did not respond or had disease recurrence after 1 course of induction chemotherapy or had positive immune residues after induction chemotherapy or positive molecular residues (if any) after induction chemotherapy. * voluntarily participate in clinical research and sign an informed consent form and be willing to follow and be able to complete all experimental procedures. * the toxic and side effects caused by the last treatment should be recovered. * eastern cooperative oncology group score of 0 to 3 points. * the organ function is intact. * alanine aminotransferase (alt) and aspartate aminotransferase (ast) ≤2×uln (upper limit of normal). * creatinine≤2×uln. * bilirubin≤2×uln. * karnofsky≥70. * the expected survival period is at least 12 weeks. * non-pregnant, non-breastfeeding women. exclusion criteria: * suffering from other untreated or unrelieved malignant tumors within 2 years. * major surgery, radiotherapy, chemotherapy, biological therapy, immunotherapy, and experimental therapy were performed within 2 weeks of the first medication. * suffering from any other known serious and/or uncontrolled disease (eg, uncontrolled diabetes; cardiovascular disease, including congestive heart failure new york heart association \[nyha\] class iii or iv, 6 months patients with myocardial infarction and poorly controlled blood pressure); chronic renal failure; or active uncontrolled infection); the investigators considered unsuitable for this clinical trial. * patients who are unwilling or unable to comply with the protocol. * currently being treated with other systemic anti-tumor or anti-tumor research drugs. * women who are pregnant or breastfeeding.

Keywords: venetoclax hypomethylation agen pd-1 inhibitor
attention bias modification treatment (abmt) for anxiety disorders in youth who do not respond to cbt

Conditions: Anxiety Disorders

Summary: first-line psychosocial treatments for anxiety disorders in children are largely exposure-based cognitive behavioral therapies (cbts). despite strong evidence supporting cbt's efficacy, for up to 50% of youth patients, symptoms of anxiety persist after a full course of treatment. what are the treatment options for these youth? unfortunately, there is not a single empirical study in the youth anxiety treatment literature that has systematically examined treatment augmentation for youth who fail to respond to cbt. empirical efforts to address this issue are important because youth who do not respond to cbt continue to suffer emotional distress and impairment associated with anxiety disorders. this study will address this gap via double-blind randomized controlled trial of attention bias modification treatment (abmt) for anxious 10-18 year-olds who did not respond to standard cbt. attention biases in threat processing have been assigned a prominent role in the etiology and maintenance of anxiety disorders. abmt utilizes computer-based protocols to implicitly modify biased attentional patterns in anxious patients. here, participants will be cbt non-responders who will be assessed by using clinical interviews and parent- and self-rated questionnaires before and after eight sessions of abmt or placebo control, and again at an eight-week follow-up. we expect to see reduction in anxiety symptoms in the attention bias modification treatment (abmt) group relative to the placebo control group. we also expect the findings to inform pathways to treatments for anxious children who do not respond to current standard first-line therapy, and to provide initial information on mechanisms of abmt efficacy.


Eligibility criteria:
inclusion criteria: to be included all youth must: 1. have received a full course of cbt and were deemed treatment non-responders. 2. they must still have a primary diagnosis of gad, sop, or sad. 3. if they have comorbid attention deficit hyperactivity disorder (adhd) or depressive disorders, it must be treated with medication and stable. 4. if they have tics or impulse control problems, those problems must be treated with medication and stable and cause minimal or no impairment. exclusion criteria: to be excluded youth must: 1. meet diagnostic criteria for organic mental disorders, psychotic disorders, pervasive developmental disorders, or mental retardation. 2. show high likelihood of hurting themselves or others. 3. have not been living with a primary caregiver who is legally able to give consent for the child's participation. 4. be a victim of previously undisclosed abuse requiring investigation or ongoing supervision. 5. be involved currently in another psychosocial treatment. 6. have a serious vision problem that is not corrected with prescription lenses. 7. have a physical disability that interferes with their ability to click a mouse button rapidly and repeatedly.

Keywords: anxiety/anxiety disorders, clinical trials, treatment, cognition, computer/internet technology
myomectomy during cesarean section is this aright decision

Conditions: Obstetric Labor, Premature

Summary: myomectomy was done during cesarean section

the myomectomy was done by conventional technique but timing of myomectomy either before or after delivery of the baby varied between different cases .infusion of oxytocin during the operation and for 24 h later.

Eligibility criteria:
inclusion criteria: * women with diagnosed uterine myoma prior to pregnancy * needed cesarean sections for various indications. * women with diagnosed uterine myoma during pregnancy and needed cesarean sections for various indications. * women with myoma diagnosed incidentally during labour. exclusion criteria: * refusal of the women at any time before and during the operations. * cervical myoma. * atonic uterus after delivery of the baby. * women with bleeding disorders due to medical or obstetric causes.